TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
US Congress
Canadian Institutes of Health Research (CIHR)
Juvenile Diabetes Research Foundation
European Foundation for the Study of Diabetes
European Community (EC)
Mead Johnson Nutrition
Finnish Diabetes Research Foundation
Academy of Finland
Dutch Diabetes Research Foundation
Information provided by (Responsible Party):
Margaret Lawson, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT00179777
First received: September 10, 2005
Last updated: February 14, 2014
Last verified: February 2014

September 10, 2005
February 14, 2014
March 2002
February 2017   (final data collection date for primary outcome measure)
Type 1 diabetes mellitus assessed by (1) blood glucose and HbA1c at 12 and 18 months of age, and annually from age 2 to 10 years, and (2) oral glucose tolerance test at 6 and 10 years of age. [ Time Frame: 12 and 18 months and annually from 2 to 10 years ] [ Designated as safety issue: No ]
Type 1 diabetes mellitus assessed by (1) blood glucose and HbA1c at 12 and 18 months of age, and annually from age 2 to 10 years, and (2) oral glucose tolerance test at 6 and 10 years of age.
Complete list of historical versions of study NCT00179777 on ClinicalTrials.gov Archive Site
Diabetes associated islet antibodies (ICA, IAA, GADA, IA-2A) at 3, 6, 9, 12 and 18 months of age, and annually from age 2 to 10 years [ Time Frame: 3, 6, 9, 12, 18 months and annually from 2 to 10 years ] [ Designated as safety issue: No ]
(1) Diabetes associated islet antibodies (ICA, IAA, GADA, IA-2A) at 3, 6, 9, 12 and 18 months of age, and annually from age 2 to 10 years, and (2) Cow's milk protein antibodies at 3, 6, 9, 12 and 18 months of age, and annually from age 2 to 10 years.
Not Provided
Not Provided
 
TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
TRIGR - Trial to Reduce IDDM in the Genetically at Risk

The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) is an international effort to conduct a primary prevention nutrition trial for type 1 (insulin-dependent) diabetes. The TRIGR study is targeted at newborns who are at genetic risk for type 1 diabetes because their mother, father and/or full sibling has type 1 diabetes. All families are encouraged to breast feed their infants for as long as possible. Prior to birth, the child is randomly assigned to receive one of two infant formulas, should formula be required prior to 8 months of age. The study will determine whether weaning to a possibly protective infant formula decreases these children's chances of developing diabetes - as it does in the animal models for diabetes.

The hypothesis for this study is that weaning to an extensively hydrolyzed infant formula will decrease the incidence of type 1 diabetes in subjects with risk-associated HLA genotypes and a first degree relative with type 1 diabetes, as it does in all relevant animal models for the disease.

Specific Aims:

I.a: To determine if weaning to a case in hydrolysate infant formula reduces the frequency of diabetes-predictive auto-antibodies in subjects with risk-associated HLA genotype and a first degree relative with type 1 diabetes (mother, father and/or full sibling).

I-b: To determine if weaning to a casein hydrolysate infant formula reduces the frequency of clinical diabetes in subjects with risk-associated HLA genotype and an affected first degree relative.

A secondary aim is to determine relationships between cow's milk antibodies, a measure of cow's milk exposure, and diabetes-associated auto-antibodies.

The mother of the unborn child is recruited during pregnancy. Randomization to one of two infant formulas takes place before birth (after 35 weeks gestation) or immediately after birth.

Experimental Arm: Use of extensively hydrolysed cow's milk based infant formula when needed in supplementation or substitution for breast milk through 6-8 months from birth.

Control Arm: Use of non-hydrolysed cow's milk based infant formula when needed in supplementation or substitution for breast milk through 6-8 months from birth.

All families are encouraged to breast feed their infants for as long as possible. The study infant formula is only used if exclusive breast feeding ceases before 8 months of age.

Cord blood for genotyping is obtained at birth, or failing that from a heel prick by 7 days of age. Only subjects with genotypes indicating increased genetic risk for type 1 diabetes remain in the intervention trial. All other subjects are withdrawn from the study.

All subjects will be followed for 10 years.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Diabetes Mellitus, Type 1
Dietary Supplement: hydrolysed vs nonhydrolysed infant formula vs breast feeding
hydrolysed vs nonhydrolysed infant formula vs breast feeding
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2032
February 2017
February 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Biological parent and/or full (not half) sibling of the newborn infant has type 1 diabetes as defined by the World Health Organization
  • The infant's parent or legal guardians give signed consent to participate

Exclusion Criteria:

  • An older sibling of the newborn infant has been included in the TRIGR intervention
  • Multiple gestation
  • The parents are unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural).
  • The newborn infant has a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.
  • The gestational age of the newborn infant is less than 35 weeks.
  • The infant is older than 7 days at randomization.
  • Inability of the family to take part in the study (e.g. the family has no access to any of the Study Centers, the family has no telephone).
  • The infant has received any infant formula other than Nutramigen prior to randomization.
  • No HLA sample drawn before the age of 8 days.
Both
up to 7 Days
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Czech Republic,   Estonia,   Finland,   Germany,   Hungary,   Italy,   Luxembourg,   Netherlands,   Poland,   Spain,   Sweden,   Switzerland
 
NCT00179777
MCT-49395, U01 HD40364, U01 HD42444
Yes
Margaret Lawson, Children's Hospital of Eastern Ontario
Children's Hospital of Eastern Ontario
  • US Congress
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Canadian Institutes of Health Research (CIHR)
  • Juvenile Diabetes Research Foundation
  • European Foundation for the Study of Diabetes
  • European Community (EC)
  • Mead Johnson Nutrition
  • Finnish Diabetes Research Foundation
  • Academy of Finland
  • Dutch Diabetes Research Foundation
Principal Investigator: Hans K Akerblom, MD Helsinki University
Children's Hospital of Eastern Ontario
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP